BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11640240 · Received April 9, 2021

    Report

    Report Number
    3007284313-2021-01375
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 8, 2021
    Report Date
    August 6, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622528
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6- CODE 4112 / 213: THE DEVICE EVALUATION WAS PERFORMED BASED ON WHAT WAS REPORTED TO GORE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT A PHYSICAL SAMPLE TO EVALUATE, THE PHYSICIAN¿S OBSERVATION THAT ¿WHEN WITHDRAWING THE DELIVERY CATHETER FROM THE PATIENT THE DELIVERY CATHETER GOT STUCK ON THE WIRE¿ COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE LIKELY CAUSE FOR THE DEVICE REPORTEDLY GETTING STUCK ON THE GUIDEWIRE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR IN A NON-TORTUOUS ANATOMY (ILIAC ARTERIES AND AORTA) WITH A GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS (RLT281412). THE DEVICE WAS ADVANCED OVER A 0.035" LUNDERQUIST¿ EXTRA-STIFF WIRE GUIDE (LENGTH 260 CM, COOK MEDICAL) AND DEPLOYED AT THE INTENDED LOCATION WITHOUT ISSUE. REPORTEDLY, WHEN WITHDRAWING THE DELIVERY CATHETER FROM THE PATIENT THE DELIVERY CATHETER GOT STUCK ON THE WIRE. THEREFORE, THE PHYSICIAN WITHDREW THE DELIVERY CATHETER WITH THE WIRE IN A TANDEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538306 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT281412 00733132622528

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization